Delivery device

Abstract

The utility model relates to a delivery device. The delivery device comprises: a handle; a steerable outer shaft extending distally from the handle; an intermediate shaft extending proximally from the handle and extending distally from the handle; and an inner shaft coaxially extending distally from the handle through the intermediate shaft and the outer shaft, and coaxially extending proximally from the handle through the intermediate shaft; wherein the intermediate shaft includes a proximal end portion extending proximally from a proximal end of the handle to an adapter, and wherein the adapter includes a first port configured to receive a guidewire and a second port configured to receive fluid from a fluid source.

Description

[0001] This application is a divisional application. The application date of the original application is April 12, 2023, the application number is 2023207981281, and the name of the invention is "Prosthetic heart valve, leaflet structure and delivery assembly for prosthetic heart valve".

[0002] CROSS-REFERENCE TO RELATED APPLICATIONS

[0003] This application claims the benefit of U.S. Provisional Application No. 63 / 362,956, filed April 13, 2022, which is incorporated herein by reference. Technical Field

[0004] The present disclosure relates to prosthetic heart valves and systems and methods for prosthetic heart valves having adjustable leaflets that can be deployed to a range of working diameters. Background Art

[0005] The human heart can suffer from various valvular diseases. These valvular diseases can cause significant dysfunction of the heart, and ultimately require repairing the natural valve or replacing the natural valve with an artificial valve. There are many known repair devices (such as stents) and artificial valves, as well as many known methods for implanting these devices and valves in the human body. In various surgeries, percutaneous and minimally invasive surgical methods are used to deliver prosthetic medical devices to a position that is not easily accessible by surgery in the body or a position that is expected to be accessible without surgery. In a specific example, a prosthetic heart valve can be mounted on the distal end of a delivery device in a curled state, and advance through the patient's vascular system (such as through the femoral artery and the aorta) until the prosthetic heart valve reaches the implantation site in the heart. Subsequently, for example, by inflating a balloon on which a prosthetic valve is mounted, a mechanical actuator that applies an expansion force to the prosthetic heart valve is actuated, or by deploying the prosthetic heart valve from the sheath of the delivery device so that the prosthetic heart valve can self-expand to its functional size, the prosthetic heart valve is expanded to its functional size.

[0006] The annular size of the natural valve can vary depending on the patient. In order to accommodate a range of annular sizes, prosthetic heart valves can be manufactured in different different sizes (e.g., different diameters, etc.). Typically, when deployed at the implantation site in the heart, the prosthetic valve can expand to only one functional size. As a result, multiple prosthetic valves are required to treat patients with different annular sizes. Therefore, a prosthetic valve that can expand to any working diameter within a working diameter range to treat patients with different annular sizes would be ideal. Utility Model Content

[0007] Prosthetic heart valves, delivery devices, and methods for assembling and implanting prosthetic heart valves are described herein. The disclosed prosthetic heart valves, delivery devices, and methods can, for example, provide versatility, wherein an expandable prosthetic heart valve has leaflets that fold in a self-adjustable manner to permit the prosthetic valve to expand to a desired diameter within a range of working diameters. Thus, the devices and methods disclosed herein can, among other things, overcome one or more deficiencies of typical prosthetic heart valves.

[0008] A prosthetic heart valve may include a frame and a valve structure including a plurality of leaflets coupled to the frame.In addition to these components, a prosthetic heart valve may include one or more of the components disclosed herein.

[0009] In some embodiments, the prosthetic heart valve can have a length of the coapted portion of the leaflets in a circumferential direction that gradually increases as the frame radially expands.

[0010] In some embodiments, a prosthetic heart valve can include a leaflet having longitudinally or axially extending folds (eg, a fold extending from an inflow edge of the leaflet to an outflow end) that define inner and outer layers of the leaflet.

[0011] In some examples, a prosthetic heart valve includes one or more of the components described in Examples 1-60 below.

[0012] In a representative example, a prosthetic heart valve includes: a radially expandable frame comprising a plurality of interconnected struts; and a plurality of leaflets disposed within the frame and configured to regulate blood flow through the frame in one direction, wherein each leaflet is folded along an axially extending fold to form an inner layer and an outer layer, wherein the inner layer of each leaflet is configured to engage with the inner layers of other leaflets, and wherein the length of the inner layer in a circumferential direction gradually increases as the frame radially expands.

[0013] In another representative example, a prosthetic heart valve includes: a frame comprising a plurality of interconnected struts, wherein the frame can radially expand between at least a first diameter and a larger second diameter; and a plurality of leaflets disposed within the frame and configured to regulate blood flow through the frame in one direction when the frame radially expands to the first diameter and when the frame radially expands to the second diameter, wherein each leaflet is folded along a longitudinal fold to form an inner layer and an outer layer, wherein each longitudinal fold defines a pair of adjacent inner layer commissures for two adjacent leaflets, wherein the inner layer of each leaflet defines a joining edge, the joining edge being configured to move inward and outward in a radial direction relative to the outer layer at the commissure.

[0014] In another representative example, a prosthetic heart valve includes: a radially expandable frame comprising a plurality of interconnected struts; and a plurality of self-adjustable leaflets disposed within the frame, each leaflet including a longitudinal fold defining an outer layer and an inner layer, wherein the inner layer of a first leaflet includes a non-engaged portion and an engaged portion, wherein the non-engaged portion of the first leaflet is disposed radially outside of the outer layer of a second leaflet, wherein each engaged portion is configured to move inward and outward in a radial direction relative to the outer layer at the longitudinal fold.

[0015] In another representative example, a prosthetic heart valve includes: a frame comprising a plurality of leaflet attachment members; and a leaflet structure disposed within the frame and attached to the frame at the plurality of leaflet attachment members, the leaflet structure defining leaflets between each of the plurality of leaflet attachment members, wherein each leaflet includes a longitudinal fold defining an inner layer and an outer layer, wherein each fold is circumferentially offset from the plurality of leaflet attachment members, wherein the inner layer of the leaflet is configured to move inward and outward in a radial direction relative to the frame to regulate blood flow through the frame.

[0016] In another representative example, a prosthetic heart valve includes: a radially expandable frame; and a leaflet structure, which is arranged in the frame and includes a plurality of leaflets, each leaflet including a longitudinal fold portion defining an inner layer and an outer layer, each inner layer having a non-bonded section and a bonded section, wherein a first outer layer is connected to a bonded section of the first inner layer and a non-bonded section of the second inner layer, wherein the first outer layer is arranged radially outside the bonded section of the first inner layer, wherein the first outer layer is arranged radially inside the non-bonded section of the second inner layer, wherein a length of the inner layer in a circumferential direction gradually increases when the leaflet assembly radially expands, and wherein a length of the outer layer in a circumferential direction gradually decreases when the leaflet assembly radially expands.

[0017] In another representative example, a leaflet structure for a prosthetic heart valve includes: three inner layers, each inner layer having a non-bonded segment and a bonded segment; three outer layers, which are connected to the three inner layers, wherein a first outer layer of the three outer layers is connected to a bonded segment of the first inner layer and a non-bonded segment of the second inner layer, wherein the first outer layer is disposed radially outside the bonded segment of the first inner layer, wherein a second outer layer of the three outer layers is connected to a bonded segment of the second inner layer and a non-bonded segment of the third inner layer, wherein the second outer layer is disposed radially inside the non-bonded segment of the third inner layer; at least one longitudinal fold portion, which is positioned between each inner layer and the corresponding outer layer; wherein the length of the inner layer in the circumferential direction gradually increases when the leaflet structure radially expands; and wherein the length of the outer layer in the circumferential direction gradually decreases when the leaflet structure radially expands.

[0018] In another representative example, a delivery assembly includes: a delivery device including an expansion mechanism; and a prosthetic heart valve connected to the delivery device, the prosthetic heart valve including: a radially expandable frame; and a plurality of leaflets disposed within the frame and configured to regulate blood flow through the frame in one direction, wherein each leaflet is folded along a longitudinal fold to form an inner layer and an outer layer, wherein the inner layer of each leaflet is configured to engage with the inner layers of other leaflets, and wherein the length of the inner layer in a circumferential direction gradually increases when the expansion mechanism radially expands the frame.

[0019] In another representative example, an implantation method includes inserting a delivery device into a patient's blood vessel, the delivery device comprising a radially expandable prosthetic heart valve; and expanding the prosthetic heart valve within or near a native valve of the patient's heart to a first diameter within a range of diameters of the prosthetic heart valve, the prosthetic heart valve comprising a leaflet having a folded portion, the folded portion defining a leaflet inner layer and a leaflet outer layer, the leaflet inner layer and the leaflet outer layer sliding relative to each other when the prosthetic heart valve expands.

[0020] In another representative example, a method of delivering an implant within a patient's body, the implant comprising a prosthetic heart valve of any of the examples herein, the method comprising positioning the prosthetic heart valve at an implantation site within the patient's body; and expanding the prosthetic heart valve to a working diameter within a working diameter range of the prosthetic heart valve.

[0021] The above methods may be performed on a live animal or on a simulated object, such as a cadaver, a cadaver heart, an anthropomorphic ghost, a simulator (eg, having simulated body parts, hearts, tissues, etc.).

[0022] The various innovations of the present disclosure may be used in combination or alone. The present disclosure is provided to introduce some concepts in a simplified form, which will be further described in the following detailed description. The present disclosure is not intended to identify the key features or essential features of the claimed subject matter, nor is it intended to be used to limit the scope of the claimed subject matter. The foregoing and other objects, features and advantages of the present disclosure will become more apparent from the following detailed description, claims and drawings.

[0023] In a representative example, the delivery device of the present application includes: a handle; a steerable outer shaft extending distally from the handle; an intermediate shaft extending proximally from the handle and extending distally from the handle; and an inner shaft, the inner shaft coaxially extending distally from the handle through the intermediate shaft and the outer shaft, and coaxially extending proximally from the handle through the intermediate shaft; wherein the intermediate shaft includes a proximal end portion extending proximally from the proximal end of the handle to an adapter, and wherein the adapter includes a first port configured to receive a guide wire and a second port configured to receive a fluid from a fluid source.

[0024] In one representative example, a rotatable knob is mounted on the proximal end portion and is configured to rotate the intermediate shaft about a central longitudinal axis and relative to the outer shaft.

[0025] In one representative example, the second port is fluidly coupled to an inner lumen of the intermediate shaft.

[0026] In one representative example, the intermediate shaft further includes a distal end portion that extends distally beyond the distal end of the outer shaft when the distal end of the outer shaft is positioned away from the inflatable balloon of the delivery device.

[0027] In one representative example, the distal portion of the inner shaft extends distally beyond the distal end portion of the intermediate shaft.

[0028] In one representative example, the inflatable balloon is coupled to the distal end portion of the intermediate shaft.

[0029] In one representative example, a distal end of the inflatable balloon is coupled to a distal end of the delivery device.

[0030] In one representative example, an annular space is defined between an outer surface of the inner shaft and an inner surface of the intermediate shaft and is configured to receive the fluid from the fluid source via the second port of the adapter.

[0031] In one representative example, the annular space is fluidly coupled to a fluid passage formed between an outer surface of a distal end portion of the inner shaft and an inner surface of the inflatable balloon.

[0032] In one representative example, wherein the handle includes a steering mechanism configured to adjust the curvature of the distal end portion of the delivery device, and wherein the handle further includes an adjustment mechanism and an associated locking mechanism. BRIEF DESCRIPTION OF THE DRAWINGS

[0033] Figure 1 is a side elevation view of a prosthetic heart valve according to one example.

[0034] Figure 2 is a side view of an example of a delivery device configured to deliver and implant a radially expandable prosthetic heart valve at an implantation site.

[0035] Figure 3 is a plan view of an outflow end of a prosthetic heart valve according to another example, with the leaflets in an open configuration.

[0036] Figure 4 yes Figure 3 A plan view of the outflow end of a prosthetic heart valve with the leaflets in a closed configuration.

[0037] Figure 5A Is expanded to the first working diameter Figure 3 A plan view of the outflow end of a prosthetic heart valve.

[0038] Figure 5B is expanded to a second working diameter that is larger than the first working diameter Figure 3 A plan view of the outflow end of a prosthetic heart valve.

[0039] Figure 5C is fully expanded to the third largest working diameter Figure 3 A plan view of the outflow end of a prosthetic heart valve.

[0040] Figure 6 yes Figure 3 Schematic partial side view of a prosthetic heart valve showing the leaflets in an open configuration.

[0041] Figure 7 yes Figure 3 Schematic partial side view of a prosthetic heart valve showing the leaflets in a closed configuration.

[0042] Figure 8 yes Figure 3Schematic partial side view of a prosthetic heart valve showing two leaflets in a flattened arrangement for illustrative purposes. DETAILED DESCRIPTION

[0043] General considerations

[0044] For the purposes of this description, certain aspects, advantages, and novel features of examples of the present disclosure are described herein. The described methods, systems, and devices should not be construed as limiting in any way. Rather, the present disclosure relates to all novel and non-obvious features and aspects of the various disclosed examples, individually and in various combinations and sub-combinations with each other. The disclosed methods, systems, and devices are not limited to any particular aspect, feature, or combination thereof, nor do the disclosed methods, systems, and devices require the presence of any one or more specific advantages or solutions to problems.

[0045] Although the operations of some disclosed examples are described in a particular sequential order for ease of presentation, it should be understood that this description includes rearrangement unless the specific language set forth below requires a particular order. For example, the operations described in sequence may be rearranged or performed simultaneously in some cases. In addition, for simplicity, the accompanying drawings may not show the various ways in which the disclosed methods can be used in conjunction with other methods. In addition, this specification sometimes uses terms such as "providing" or "implementing" to describe the disclosed methods. These terms are high-level abstractions of the actual operations performed. The actual operations corresponding to these terms may vary depending on the specific implementation, and are easily discernible by those of ordinary skill in the art.

[0046] As used in this application and the claims, the singular forms "a", "an", and "the" include the plural forms unless the context clearly dictates otherwise. In addition, the term "comprising" means "including". Furthermore, the term "coupled" generally means a physical, mechanical, chemical, magnetic, and / or electrical connection or coupling, and in the absence of specific language to the contrary does not exclude the presence of intervening elements between the coupled or associated items.

[0047] As used herein, the term "proximal" refers to a position, direction or part of a device that is closer to a user and further away from an implantation site. As used herein, the term "distal" refers to a position, direction or part of a device that is further away from a user and closer to an implantation site. Thus, for example, the proximal movement of a device is the movement of the device away from the implantation site and toward the user (e.g., leaving the patient's body), while the distal movement of the device is the movement of the device away from the user and toward the implantation site (e.g., entering the patient's body). The terms "longitudinal" and "axial" refer to axes extending in proximal and distal directions, unless otherwise clearly defined.

[0048] Examples of Public Technology

[0049] Examples of radially expandable and compressible prosthetic heart valves including an annular frame are described herein. In some examples, the frame of the prosthetic heart valve can include a plurality of cell rows formed by interconnected struts of the frame. The plurality of cell rows can be formed between an inflow end and an outflow end of the frame.

[0050] The prosthetic heart valve can also include a plurality of leaflets coupled to the frame.In some examples, the leaflets can include a folded pattern that defines a leaflet inner layer and a leaflet outer layer.

[0051] In some examples, during the operating cycle of the valve, the leaflet outer layers can remain relatively stationary relative to the frame. The leaflet inner layers can move inwardly and outwardly relative to the frame and contact other leaflet inner layers to regulate flow through the valve in one direction.

[0052] The prosthetic valve disclosed herein can be radially compressed and expanded between a radially compressed state and a radially expanded state. Thus, during delivery, the prosthetic valve can be crimped on or held by an implant delivery device in a radially compressed state, and then expanded to a radially expanded state once the prosthetic valve reaches the implantation site. It should be understood that the prosthetic valve disclosed herein can be used with a variety of implant delivery devices and can be implanted via a variety of delivery procedures, examples of which will be discussed in more detail later.

[0053] In some examples, a prosthetic heart valve can be radially expanded to a range of working diameters. For example, a prosthetic heart valve at a first working diameter in a radially expanded state can have a leaflet outer layer that is relatively longer in a circumferential direction than a leaflet inner layer. When the prosthetic heart valve expands to a second larger working diameter, the leaflet inner layer can stretch to tighten slack from the leaflet outer layer. At the second larger working diameter, the leaflet inner layer is longer in the circumferential direction than the leaflet outer layer. Therefore, the length of the leaflet inner layer (e.g., the joint portion of the leaflet) can gradually increase in the circumferential direction when the prosthetic heart valve expands radially. This allows a prosthetic heart valve to adapt to a range of patient annulus sizes.

[0054] Figure 1An exemplary prosthetic valve 10 according to one example is shown. Any of the prosthetic valves disclosed herein is suitable for implantation in a native aortic valve annulus, but in other examples, the prosthetic valve may be suitable for implantation in other native valve annuli of the heart (pulmonary valve, mitral valve, and tricuspid valve). The disclosed prosthetic valve may also be implanted in a blood vessel connected to the heart, including the pulmonary artery (to replace the function of a diseased pulmonary valve), or the superior vena cava or inferior vena cava (to replace the function of a diseased tricuspid valve), or various other veins, arteries, and blood vessels of the patient. The disclosed prosthetic valve may also be implanted in a previously implanted prosthetic valve (which may be a prosthetic surgical valve or a prosthetic transcatheter heart valve) during a valve-in-valve procedure.

[0055] In some examples, the disclosed prosthetic valve can be implanted in a docking or anchoring device implanted in a natural heart valve or blood vessel. For example, in one example, the disclosed prosthetic valve can be implanted in a docking device implanted in the pulmonary artery to replace the function of a diseased pulmonary valve, such as disclosed in U.S. Publication 2017 / 0231756, which is incorporated herein by reference. In another example, the disclosed prosthetic valve can be implanted in a docking device implanted in or at a natural mitral valve, such as disclosed in PCT Publication WO2020 / 247907, which is incorporated herein by reference. In another example, the disclosed prosthetic valve can be implanted in a docking device implanted in the superior vena cava or the inferior vena cava to replace the function of a diseased tricuspid valve, such as disclosed in U.S. Publication 2019 / 0000615, which is incorporated herein by reference.

[0056] The prosthetic valve 10 includes four main components: a stent or frame 12, a valve structure 14, an inner skirt 16, and a perivalvular sealing member or outer skirt 18. The prosthetic valve 10 can have an inflow end portion 15, a middle portion 17, and an outflow end portion 19. The inner skirt 16 can be disposed on and / or coupled to an inner surface of the frame 12, while the outer skirt 18 can be disposed on and / or coupled to an outer surface of the frame 12.

[0057] The valve structure 14 may include three leaflets 40 that together form a leaflet structure that can be arranged to collapse in a tricuspid arrangement, but in other examples, there may be a greater or lesser number of leaflets (e.g., one or more leaflets 40). The leaflets 40 may be fastened to each other at their adjacent sides to form the commissures 22 of the leaflet structure 14. The lower edge of the valve structure 14 may have a wavy curved fan-shaped shape and may be fastened to the inner skirt 16 by sutures (not shown). In some examples, the leaflets 40 may be formed of pericardial tissue (e.g., bovine pericardial tissue), biocompatible synthetic materials, or various other suitable natural or synthetic materials, as known in the art and described in U.S. Patent No. 6,730,118, which is incorporated herein by reference. As described in more detail below, in some examples, the leaflets 40 may be folded to form new commissures that are circumferentially offset from the commissures 22. In these examples, the folding pattern of leaflet 40 can enable the leaflet to self-adjust, such that leaflet 40 is operable to regulate blood flow at each diameter within a range of diameters.

[0058] The frame 12 may be radially compressible (collapsible) and expandable (e.g. Figure 1 ) and includes a plurality of interconnected struts 24. A plurality of circumferentially spaced tops 26 are formed at the inflow end portion 15 and the outflow end portion 19 of the frame 12 (at Figure 1 Only the top end 26 at the outflow end portion 19 is visible. Each top end 26 is formed at the junction between two angled struts 24 at the inflow end portion 15 or the outflow end portion 19. Figure 1 A known frame design is depicted having an apex 26 that forms a U-shaped bend between two angled struts 24. In some examples, the angle 30 between the two angled struts 24 connected at the apex 26 may be in the range of 90 to 120 degrees.

[0059] The frame 12 can be formed with a plurality of circumferentially spaced grooves or commissure windows 20 suitable for mounting the commissure 22 of the valve structure 14 to the frame. The frame 12 can be made of any material in various suitable plastic expansion materials (e.g., stainless steel, etc.) or shape memory materials, self-expanding materials (e.g., Nitinol). When constructed of plastic expansion materials, the frame 12 (and therefore the prosthetic valve 10) can be curled into a radially collapsed configuration on a delivery catheter or device, and then expanded in the patient's body by an inflatable balloon or an equivalent expansion mechanism. When constructed of self-expandable materials, the frame 12 (and therefore the prosthetic valve 10) can be curled into a radially collapsed configuration, and be restrained in a collapsed configuration by being inserted into a sheath or an equivalent mechanism of a delivery catheter. Once inside the body, the prosthetic valve can be advanced from the delivery sheath, which allows the prosthetic valve to expand to its functional size.

[0060] Suitable plastically expandable materials that can be used to form the frame 12 include metal alloys, polymers, or combinations thereof. Example metal alloys may include one or more of the following: nickel, cobalt, chromium, molybdenum, titanium, or other biocompatible metals. In some examples, the frame 12 may include stainless steel. In some examples, the frame 12 may include a cobalt-chromium alloy. In some examples, the frame 12 may include a nickel-cobalt-chromium alloy. In some examples, the frame 12 includes a nickel-cobalt-chromium-molybdenum alloy, such as MP35N. TM (Trade name of SPS Technologies), which is equivalent to UNS R30035 (covered by ASTM F562-02). MP35N TM / UNS R30035 contains 35% nickel, 35% cobalt, 20% chromium, and 10% molybdenum by weight. Additional details regarding the prosthetic valve 10 and its various components are described in WIPO patent application publication WO 2018 / 222799, which is incorporated herein by reference.

[0061] Figure 2 A delivery device 100 is shown according to an example that can be used to implant an expandable prosthetic heart valve (e.g., Figure 1

[0046] The delivery device 100 may be used to deliver a prosthetic heart valve 10 of the present invention and / or any of the other prosthetic heart valves described herein. In some examples, the delivery device 100 is particularly suitable for introducing a prosthetic valve into the heart.

[0062] Figure 2 The delivery device 100 in the illustrated example is a balloon catheter, which includes a handle 102 and a steerable outer shaft 104 extending distally from the handle 102. The delivery device 100 may also include an intermediate shaft 106 (also referred to as a balloon shaft) extending proximally from the handle 102 and extending distally from the handle 102, and the portion extending distally from the handle 102 also coaxially extends through the outer shaft 104. In addition, the delivery device 100 may also include an inner shaft 108, which coaxially extends distally from the handle 102 through the intermediate shaft 106 and the outer shaft 104, and coaxially extends proximally from the handle 102 through the intermediate shaft 106.

[0063] The outer shaft 104 and the intermediate shaft 106 may be configured to longitudinally translate (eg, move) relative to one another along a central longitudinal axis 120 of the delivery device 100 to facilitate delivery and positioning of a prosthetic valve at an implantation site within a patient's body.

[0064] The intermediate shaft 106 may include a proximal end portion 110 extending proximally from the proximal end of the handle 102 to the adapter 112. A rotatable knob 114 may be mounted on the proximal end portion 110 and may be configured to rotate the intermediate shaft 106 about the central longitudinal axis 120 and relative to the outer shaft 104.

[0065] The adapter 112 can include a first port 138 configured to receive a guidewire therethrough and a second port 140 configured to receive a fluid (eg, an inflation fluid) from a fluid source. The second port 140 can be fluidly coupled to the inner lumen of the intermediate shaft 106.

[0066] The intermediate shaft 106 can also include a distal end portion that extends distally beyond the distal end of the outer shaft 104 when the distal end of the outer shaft 104 is positioned away from the inflatable balloon 118 of the delivery device 100. The distal portion of the inner shaft 108 can extend distally beyond the distal end portion of the intermediate shaft 106.

[0067] The balloon 118 can be coupled to the distal end portion of the intermediate shaft 106 .

[0068] In some examples, the distal end of the balloon 118 can be coupled to the distal end of the delivery device 100, such as to the nose cone 122 (eg, Figure 2 ), or an alternative component (e.g., a distal shoulder) coupled to the distal end of the delivery device 100. The middle portion of the balloon 118 can cover the valve mounting portion 124 of the distal end portion of the delivery device 100, and the distal end portion of the balloon 118 can cover the distal shoulder 126 of the delivery device 100. The valve mounting portion 124 and the middle portion of the balloon 118 can be configured to receive a prosthetic heart valve in a radially compressed state. For example, as Figure 2 As schematically shown in , a prosthetic heart valve 150 , which may be one of the prosthetic valves described herein, may be mounted around a balloon 118 at a valve mounting portion 124 of the delivery device 100 .

[0069] The balloon shoulder assembly, including the distal shoulder 126, is configured to maintain the prosthetic heart valve 150 (or other medical device) in a fixed position on the balloon 118 during delivery through the patient's vasculature.

[0070] The outer shaft 104 may include a distal tip portion 128 mounted on its distal end. Figure 2), and during delivery of the prosthetic valve to a target implantation site, the outer shaft 104 and the intermediate shaft 106 can be axially translated relative to each other to position the distal tip portion 128 adjacent to the proximal end of the valve mounting portion 124. Thus, the distal tip portion 128 can be configured to resist proximal movement of the prosthetic valve 150 relative to the balloon 118 in an axial direction when the distal tip portion 128 is disposed adjacent to the proximal side of the valve mounting portion 124.

[0071] An annular space can be defined between the outer surface of the inner shaft 108 and the inner surface of the intermediate shaft 106, and can be configured to receive fluid from a fluid source via the second port 140 of the adapter 112. The annular space can be fluidly coupled to a fluid passage formed between the outer surface of the distal end portion of the inner shaft 108 and the inner surface of the balloon 118. Thus, fluid from the fluid source can flow from the annular space to the fluid passage to inflate and radially expand the balloon 118 and deploy the prosthetic valve 150.

[0072] The inner lumen of the inner shaft can be configured to receive a guidewire therethrough for guiding the distal end portion of the delivery device 100 to a target implantation site.

[0073] The handle 102 may include a steering mechanism configured to adjust the curvature of the distal end portion of the delivery device 100. In the example shown, for example, the handle 102 includes an adjustment member, such as a rotatable knob 160 shown, which is in turn operatively connected to the proximal end portion of the traction wire. The traction wire can extend distally from the handle 102 through the outer shaft 104 and have a distal end portion fixed to the outer shaft 104 at or near the distal end of the outer shaft 104. Rotating the knob 160 can increase or decrease the tension in the traction wire, thereby adjusting the curvature of the distal end portion of the delivery device 100. Further details about the steering or flexing mechanism for the delivery device can be found in U.S. Patent No. 9,339,384, which is incorporated herein by reference.

[0074] The handle 102 may also include an adjustment mechanism 161 and an associated locking mechanism, the adjustment mechanism including an adjustment member, such as the rotatable knob 162 shown, the locking mechanism including another adjustment member configured as a rotatable knob 178. The adjustment mechanism 161 is configured to adjust the axial position of the intermediate shaft 106 relative to the outer shaft 104 (e.g., for fine positioning at the implantation site). Further details about the delivery device 100 can be found in PCT application PCT / US2021 / 047056, which is incorporated herein by reference.

[0075] Figure 3An example of a prosthetic heart valve 200 is shown that includes a radially expandable and compressible annular frame 202 and a valve structure or leaflet assembly that includes a plurality of leaflets 204 (e.g., three in the example shown) coupled to the frame 202. Each leaflet 204 may include a fold 206 that extends longitudinally or axially. The fold 206 may extend axially from the inflow end of the frame 202 toward the outflow end (e.g., from an inflow or pointed edge portion of the leaflet 204 toward the outflow edge of the leaflet, etc.). In some examples, the fold 206 may extend parallel to the longitudinal axis of the valve 200. In some examples, the axially extending fold 206 may extend at an oblique angle relative to the longitudinal axis of the valve 200 (such as at an angle to the longitudinal axis of the valve 200). Figure 6 ). An axially extending fold 206 defines an inner layer 208 of the leaflet 204 and an outer layer 210 of the leaflet 204. At the fold 206, the inner layer 208 is disposed radially inward of the outer layer 210. Both the inner layer 208 and the outer layer 210 are positioned radially inward of the frame 202 (e.g., within the frame 202).

[0076] The frame 202 can be made of various suitable plastically expandable materials (e.g., stainless steel, cobalt-chromium alloy, etc.) or of self-expanding materials (e.g., nitinol). In some examples, the frame 202 includes a plastically expandable material, such as the one described above with reference to Figure 1 The frame 202 may be made of any of the materials described for the prosthetic heart valve 10. Figure 1 The frame 12 is similar or identical.

[0077] The leaflet 204 can be secured to the frame 202 directly or indirectly using sutures. For example, the leaflet 204 can be secured to the frame 202 along a plurality of axially extending suture attachment lines 212 (also referred to as sutures) defined by a plurality of sutures that directly secure the axially extending side edges of the outer layer 210 of the leaflet to the frame 202. Along each suture attachment line 212, the suture can be, for example, a continuous in-and-out suture that extends through the outer layer 210 of the leaflet 204 and through an aperture (not shown) in the frame 202. Various other suturing techniques can be used. For example, the suture can be a whip suture or a circular suture that extends through the leaflet and completely around a component of the frame 202 (e.g., around a selected strut of the frame). In other examples, the sutures in each suture attachment line 212 can be discrete (discontinuous) sutures. Although not required, the suture attachment line 212 desirably extends the entire height of the leaflet 204 from the inflow edge of the leaflet 204 to the outflow edge of the leaflet 204 .

[0078] In other examples, leaflets 204 can be coupled to frame 202 via an inner skirt radially located between the inner surface of frame 202 and the outer surface of leaflets 204. For example, prosthetic valve 200 can include an inner skirt (e.g., a fabric skirt) similar to inner skirt 16 that is formed with a plurality of ribs. Figure 1 204 or otherwise attached to the frame 202 in the manner shown in . The leaflets 204 can be directly attached to the inner skirt along corresponding suture attachment lines 212 formed by sutures extending through the leaflets 204 and the inner skirt, but need not extend around or through any part of the frame 202. In this way, the pointed edge portions of each leaflet 204 are coupled to the frame via the inner skirt. In other examples, the pointed edge portions of the leaflets 204 can be directly connected to selected struts of the frame 202 (e.g., using sutures), and the inner skirt can be optional.

[0079] In some cases, the suture attachment line 212 may be u-shaped (fan-shaped) or v-shaped. Figures 6 to 8 As shown in , each leaflet 204 can have a pointed edge portion 220 (also referred to as an inflow edge portion) that generally corresponds to and follows the shape of the suture line 212 from a first position at or near the outflow edge 222 of the leaflet 204 to a second position at or near the outflow edge 222 of the leaflet 204. For purposes of illustration, Figure 6 to Figure 7 Only one leaflet 204 of the prosthetic valve is shown, and Figure 8 Only two leaflets 204 of the prosthetic valve are shown. Figures 6 to 8 The prosthetic valve in may include two or more leaflets 204 (such as three leaflets) folded in the same manner. Suture 212 is Figures 6 to 8 In the figure, dashed lines are shown (e.g., indicating entry and exit sutures, etc.). Figures 6 to 8 In the view shown in , portions of the suture 212 are partially obscured from view by the leaflets 204 and are shown using smaller dashed lines.

[0080] exist Figures 6 to 8 In the example of FIG. 1 , each leaflet 204 can have a commissure 228, each of which mates with an adjacent commissure 228 of an adjacent leaflet 204 to form a commissure connected to the frame 202, such as a commissure 22 ( Figure 1) is formed and connected to the frame 12. Axially extending folds 206 can be formed at locations circumferentially located between the commissures 228 (and circumferentially located between adjacent commissures). Each fold 206 extends from a pointed edge portion 220 to the outflow edge 222 of the leaflet. The pointed edge portion 220 of each leaflet 204 can extend from one commissure 228 to another commissure 228. The pointed edge portion 220 can be sutured to an inner skirt (such as inner skirt 16) along suture lines 212, wherein the inner skirt is sutured or otherwise secured to the frame 202. Alternatively, the pointed edge portion 220 can be sutured directly to the struts of the frame 202 along suture lines 212. In Figures 6 to 8 In the view shown in , one or more portions of the commissure 238 are partially obscured from view by the leaflets 204, and these portions are shown using dashed lines.

[0081] The leaflets 204 may be formed from one or more sheets of material. In the example shown, the leaflets 204 are formed from one continuous sheet of material (which may be referred to as a leaflet structure or valve structure). Figure 3 As shown in FIG, the sheet of material forming the leaflet 204 is attached to the frame 202 at three locations using suture attachment lines 212 and at Figure 3 folded in the manner shown in , to define three leaflets 204 between suture lines 212. Thus, each leaflet 204 is defined as a segment of the leaflet structure between one suture attachment line 212 and a circumferentially adjacent suture attachment line 212. The leaflet structure can be rectangular and define rectangular leaflets between suture attachment lines 212, or can define a plurality of (e.g., three) v-shaped or u-shaped leaflets connected side by side. It should be understood that in other examples, the prosthetic heart valve 200 can include a different number of leaflets (e.g., one or two leaflets 204 or more than three leaflets).

[0082] In some examples, the leaflet configuration or valve structure can include a leaflet assembly that includes leaflets 204, each leaflet being formed from a separate sheet of material. In these examples, each longitudinal side edge (axially extending side edge) of a leaflet 204 can be paired with an adjacent longitudinal side edge of an adjacent leaflet 204, and the longitudinal side edge pairs can be attached to the frame via suture attachment lines 212. Alternatively, the adjacent longitudinal side edges of adjacent leaflets 204 can be circumferentially spaced from each other and attached to the frame 202 at separate circumferentially spaced locations on the frame 202. For example, for a prosthetic valve having three leaflets 204, each leaflet having two opposing longitudinal side edges, the frame 202 can have six leaflet attachment locations, each longitudinal side edge being attached to a corresponding leaflet attachment location of the frame 202. In other examples, each individually formed leaflet 204 can be v-shaped or u-shaped (e.g., having a v-shaped or u-shaped pointed portion) when in a flattened and fully expanded state.

[0083] In some examples, each leaflet of the leaflet assembly can be formed from multiple pieces of material that are sewn or otherwise attached to each other.For example, the inner layer 208 and the outer layer 210 of the leaflet 204 can be formed from separate pieces of material.

[0084] In some examples, leaflets 204 can be formed from pericardial tissue (e.g., bovine pericardial tissue), biocompatible synthetic materials, or various other suitable natural or synthetic materials, as known in the art and described in U.S. Patent 6,730,118, which is incorporated herein by reference.

[0085] In some examples, each leaflet 204 can include more than one longitudinal fold 206 between the inner layer 208 and the outer layer 210 of the leaflet 204. For example, the leaflet 204 can be folded multiple times between the inner layer 208 and the outer layer 210 in an accordion-style fold pattern.

[0086] The inner layer 208 of each leaflet 204 can include a non-engaged portion 214 and an engaged portion 216. The non-engaged portion 214 and the engaged portion 216 of the leaflet 204 are also referred to herein as the "non-engaged section" and the "engaged section" of the leaflet 204, respectively. The transition between the non-engaged portion 214 and the engaged portion 216 of the leaflet 204 is aligned with the fold 206 of the adjacent leaflet 204. As described in more detail below, during the working cycle of the valve 200, the non-engaged portion 214 can remain relatively stationary relative to the frame 202. During the working cycle of the valve 200, the engaged portion 216 can move inward and outward in a radial direction relative to the frame 202 and engage with other engaged portions 216 of the leaflet 204.

[0087] The non-coapted portion 214 of the inner layer 208 of one leaflet 204 can be positioned radially outward of the outer layer 210 of an adjacent leaflet 204. Specifically, the non-coapted portion 214 of one leaflet 204 overlaps the outer layer 210 of the adjacent leaflet 204. The coapted portion 214 of one leaflet 204 is positioned radially inward of the outer layer 210 of the same leaflet 204. Thus, in other words, at certain locations, the leaflet configuration can form three layers of leaflet material, namely, the non-coapted portion 214 of the first leaflet 204, the outer layer 210 of the second leaflet 204 radially inward of the non-coapted portion, and the coapted portion 216 of the second leaflet 204 radially inward of the outer layer. The outer layer 210 and the non-coapted portion 214 of the leaflets 204 provide additional material or slack that the coapted portion 216 of the leaflets 204 can use to increase the length of the coapted portion 216 when the prosthetic heart valve 200 is radially expanded, as described in more detail below.

[0088] like Figure 3As shown in , the fold 206 is circumferentially offset from the suture attachment line 212. The transition between the non-joined portion 214 and the joined portion 216 of the inner layer 208 of the first leaflet 204 and the position 218 aligned with the fold 206 of the second leaflet defines the commissure of the first leaflet and the second leaflet. This commissure 218 can be referred to as the "new commissure" of the first leaflet and the second leaflet because its position along the inner layer and the spacing between adjacent commissures can vary depending on the degree of radial expansion of the frame, as further described below. The joined portion 216 of each leaflet can be hinged at the corresponding fold 206 and the second new commissure 218 that define the first new commissure 218. In this example, the new commissure 218 is circumferentially offset from the position where the ends of two adjacent leaflets 204 meet (e.g., at the suture line 212).

[0089] During the operating cycle of the valve 200, the non-coapted portions 214 of the inner layer 208 of each leaflet 204 remain substantially stationary relative to the frame 202. The outer layer 210 of each leaflet 204 also remains substantially stationary relative to the frame 202. The coapted portions 216 of the inner layer 208 can move inwardly and outwardly relative to the outer layer 210 at the new commissures 218. The coapted portions 216 of the inner layer 208 define coapted edges of a leaflet 204 that can contact coapted edges of other leaflets 204.

[0090] Over time, tissue ingrowth can occur along non-engaged portions 214 to secure non-engaged portions 214 to the inner surface of frame 202. In some examples, tissue ingrowth can propagate through non-engaged portions 214 and occur along outer layer 210 to secure outer layer 210 to non-engaged portions 214 and the inner surface of frame 202. In some examples, anchors (e.g., staples, sutures, etc.) can be used to secure non-engaged portions 214 and / or outer layer 210 to the inner surface of frame 202 after the prosthetic valve is implanted in a patient.

[0091] Figure 3 to Figure 4 Two phases of the working cycle of the prosthetic heart valve 200 are shown. Specifically, Figure 3 A first phase of the operating cycle is shown, wherein the leaflets 204 of the prosthetic heart valve 200 are in an open configuration, and Figure 4 A second phase of the operating cycle is shown, wherein leaflets 204 of prosthetic heart valve 200 are in a closed configuration. Figure 6 to Figure 7 A side view of two stages of the working cycle of the prosthetic heart valve 200 is shown. Specifically, Figure 6 shows a first stage of the operating cycle when the leaflets 204 of the prosthetic heart valve 200 are in an open configuration, and Figure 7 The second phase of the operating cycle is shown when the leaflets 204 of the prosthetic heart valve 200 are in the closed configuration (although Figure 6and Figure 7 Only one leaflet 204 is shown, but the other leaflets 204 will move between the open and closed configurations in the same manner. Figure 3 to Figure 4 as well as Figure 6 to Figure 7 , the outer layer 210 and the non-engaged portion 214 of the leaflet 204 are in substantially the same position in the open configuration and the closed configuration. In some examples, this is due to tissue ingrowth above the outer layer 210 and the non-engaged portion 214 of the leaflet 204. In the closed configuration, the engaged portion 216 of the leaflet 204 is in a radially inward position relative to the frame 202, so that the engaged portion 216 of one leaflet 204 contacts the engaged portion 216 of the other leaflet 204. When the leaflet 204 is in the closed configuration, blood is prevented from passing through the valve 200. During the working cycle, the prosthetic heart valve 200 alternates between the open configuration and the closed configuration. This enables the prosthetic heart valve 200 to regulate blood flow in one direction.

[0092] To accommodate the range of working diameters, the leaflets 204 are self-adjustable as the frame 202 expands. When the frame 202 is in a radially compressed state, the outer layer 210 of each leaflet 204 can be relatively longer in the circumferential direction than the inner layer 208 along the outflow edge 222. As the frame 202 radially expands during the implantation process, the length of the inner layer 208 in the circumferential direction increases along the outflow edge 222, while the length of the outer layer 210 decreases along the outflow edge 222 due to the presence of the fold 206. In other words, as the frame 202 radially expands, the outer layer 210 provides slack that is taken up by the inner layer 208 along the outflow edge 222. As described above, the pointed edge or inflow edge portion 220 of each leaflet 204 is secured to the frame 202 at the suture attachment line 212. Therefore, as the frame radially expands, the curvature of the inflow edge portion 220 decreases, and the length of the inflow edge portion 220 of the leaflet 204 does not change. Furthermore, as the frame 202 radially expands, the position and spacing between the new commissures 218 change due to the presence of the folds 206 .

[0093] FIG. 5A to FIG. 5C The frame 202 of the prosthetic heart valve 200 is shown as the first working diameter ( Figure 5A ) radially expands to a second larger working diameter ( Figure 5B ) and the third maximum working diameter ( Figure 5C ) is an example of self-adjustment of leaflet 204. FIG. 5A to FIG. 5C The leaflets 204 are shown in an open configuration. Due to the nature of the fold 206, the prosthetic heart valve 200 includes the same number of leaflets 204 at each diameter within the working diameter range (e.g., in a compressed state, in an expanded state, at each diameter, etc.). In the example shown, three leaflets 204 are shown.

[0094] As described above, the prosthetic valve 200 can be expanded to a working diameter within a working diameter range (e.g., 20 mm to 30 mm, 25 mm to 40 mm, 40 mm to 60 mm, etc.). At each working diameter within the range, the leaflet 204 is configured to regulate blood flow through the valve 200 in one direction. Specifically, the joint portions 216 of the inner layer 208 of the leaflet 204 move inwardly and outwardly in the radial direction relative to the outer layer 210 at the fold 206, and the joint portions 216 contact each other, thereby preventing blood flow from passing through the valve 200 in one direction.

[0095] Figure 5A The prosthetic heart valve 200 is shown expanded to a first working diameter (e.g., a diameter at the lower end of a working diameter range, etc.). In this example, a large portion of the leaflets 204 overlap, and the folds 206 are offset in the circumferential direction from the corresponding suture attachment lines 212. As shown, the length of the coapted portion 216 of each leaflet 204 is relatively shorter than the remainder of the leaflet 204 (e.g., the non-coapted portion 214 and the outer layer 210).

[0096] Figure 5B The prosthetic heart valve 200 is shown expanded to a second, larger working diameter. During initial implantation of the prosthetic valve 200, the prosthetic heart valve 200 can be gradually increased to a desired diameter within a range of diameters, rather than having incremental steps between diameters. In this way, the prosthetic heart valve 200 smoothly transitions from one working diameter to the next working diameter. Specifically, when the valve 200 is expanded (e.g., by inflating the balloon 118, actuating one or more actuators of a delivery device, or deploying the prosthetic valve from a sheath to allow the prosthetic valve to self-expand), the inner layer 208 of the leaflet 204 slides relative to the outer layer 210 of the leaflet 204, which causes the fold 206 to move in a circumferential direction toward the suture attachment line 212. Similarly, the new commissure 218 also moves in a circumferential direction toward the suture attachment line 212. As shown in the example shown, in the embodiment shown, the fold 206 is moved in a circumferential direction toward the suture attachment line 212. Figure 5A When the frame 202 expands to the first diameter, the distance between adjacent folded portions 206 is greater than Figure 5B When the frame 202 expands to the second diameter, the distance between adjacent folded portions 206 is shorter. Figure 5A When the frame 202 expands to the first diameter, the distance between the adjacent new joints 218 is greater than that in Figure 5B When the frame 202 expands to the second diameter, the distance between adjacent new joints 218 is shorter.

[0097] Radially expanding the prosthetic heart valve 200 reduces the offset between the suture attachment line 212 and the fold 206, thereby causing a smaller portion of the leaflets 204 to overlap. In other words, as the frame 202 radially expands, the length of the coapted portions 216 of the leaflets 204 increases, and the length of the overlapping outer layer 210 and non-coapted portions 214 decreases. During this expansion, the coapted portions 216 use or gather material from the outer layer 210 and non-coapted portions 214 of the leaflets 204 to achieve this increased length.

[0098] like Figure 5C As shown in FIG. 1 , at the upper end of the range, the leaflets 204 can be fully expanded so that each leaflet 204 forms a single layer. At the maximum working diameter in the range, the entire length of the leaflet 204 is joined to the other leaflets 204. In this example, the leaflet 204 no longer includes an inner layer and an outer layer, and no longer includes a fold. Therefore, the commissures of the leaflets are located at the suture attachment line 212.

[0099] Thus, a single prosthetic valve 200 can be implanted in patients having a range of annulus sizes. With known prosthetic heart valves, hospitals typically stock between three and four different sizes of the same type of valve (e.g., a 20-mm valve, a 23-mm valve, a 26-mm valve, and a 29-mm valve) to treat patients having different annulus sizes. Advantageously, a single valve 200 can be used to treat patients spanning a range of patient annulus sizes (e.g., 20 mm to 30 mm). Thus, a hospital can stock a single type of valve 200 to treat the same number of patients, rather than three or four different sizes of the same valve.

[0100] In addition, in some specific implementations, the prosthetic valve 200 can be configured to further expand at a certain time after the initial implantation and / or can further self-expand to adapt to the patient's growth, such as days, weeks, months or years after the initial implantation. For example, if the frame 202 is formed of a plastically expandable material, the prosthetic valve can be further expanded in a subsequent process after its initial implantation by the following operations: a catheter with an expansion mechanism (e.g., an inflatable balloon) is delivered into the body, and the expansion mechanism is positioned in the prosthetic valve. The expansion mechanism can then expand to further expand the prosthetic valve to a larger diameter (so that the leaflets automatically adjust and form a longer leaflet joint portion), which allows a larger amount of blood to flow through the prosthetic valve. If the frame 202 is formed of a shape memory (self-expandable) material (e.g., nitinol), the frame can self-expand over time as the size of the natural valve ring increases. As the frame self-expands over time, the leaflets automatically adjust (the joint portion becomes longer) to the larger size of the frame. In some cases, even with the use of a self-expandable frame, it may be necessary or desirable to use a catheter with an expansion mechanism during a subsequent procedure to further expand the prosthetic valve or to assist in radial expansion of the frame.

[0101] In some such examples, the prosthetic valve may include an outer skirt (e.g., outer skirt 18) extending around the outer surface of the frame to prevent or minimize ingrowth of tissue on the non-engaged portion 214 of the leaflet and / or the outer layer 210, thereby allowing the leaflet to self-adjust as the prosthetic valve further expands.

[0102] Delivery Technology

[0103] In order to implant the prosthetic valve in the natural aortic valve via the transfemoral delivery method, the prosthetic valve is installed along the distal end portion of the delivery device under radial compression. The distal end portion of the prosthetic valve and the delivery device is inserted into the femoral artery, and is advanced into and through the descending aorta, around the aortic arch and through the ascending aorta. The prosthetic valve is positioned in the natural aortic valve and radially expanded to a diameter within the working diameter (e.g., by inflating a balloon, actuating one or more actuators of the delivery device, or deploying the prosthetic valve from the sheath to allow the prosthetic valve to self-expand). Alternatively, the prosthetic valve can be implanted in the natural aortic valve in a transapical surgery, whereby the prosthetic valve (on the distal end portion of the delivery device) is introduced into the left ventricle through the surgical opening in the chest and the apex, and the prosthetic valve is positioned in the natural aortic valve. Alternatively, in a transaortic procedure, the prosthetic valve (on the distal end portion of the delivery device) is introduced into the aorta through a surgical incision in the ascending aorta, such as through a partial J-shaped sternotomy or a right parasternal mini-thoracotomy, and is subsequently advanced through the ascending aorta toward the native aortic valve.

[0104] To implant a prosthetic valve into the native mitral valve via a transseptal delivery method, the prosthetic valve is mounted along the distal end portion of the delivery device in a radially compressed state. The prosthetic valve and the distal end portion of the delivery device are inserted into the femoral vein and advanced into and through the inferior vena cava, into the right atrium, through the atrial septum (through a perforation made in the atrial septum), into the left atrium, and advanced toward the native mitral valve. Alternatively, the prosthetic valve can be implanted into the native mitral valve in a transapical procedure, whereby the prosthetic valve (on the distal end portion of the delivery device) is introduced into the left ventricle through a surgical opening in the chest and the apex of the heart, and the prosthetic valve is positioned within the native mitral valve.

[0105] To implant the prosthetic valve into the native tricuspid valve, the prosthetic valve is mounted along the distal end portion of the delivery device in a radially compressed state. The prosthetic valve and the distal end portion of the delivery device are inserted into the femoral vein and advanced into and through the inferior vena cava and into the right atrium, and the prosthetic valve is positioned within the native tricuspid valve. A similar method can be used to implant the prosthetic valve into the native pulmonary valve or pulmonary artery, except that the prosthetic valve is advanced through the native tricuspid valve into the right ventricle and toward the pulmonary valve / pulmonary artery.

[0106] Another delivery method is a transatrial approach, in which the prosthetic valve (on the distal end portion of the delivery device) is inserted through an incision in the chest and through an incision made through the atrial wall (of the right or left atrium) for access to any native heart valve. Atrial delivery can also be performed intravascularly, such as from the pulmonary veins. Yet another delivery method is a transventricular approach, in which the prosthetic valve (on the distal end portion of the delivery device) is inserted through an incision in the chest and through an incision made through the right ventricular wall (usually at or near the base of the heart) for implantation of the prosthetic valve into the native tricuspid valve, the native pulmonary valve, or the pulmonary artery.

[0107] In all delivery methods, the delivery device can be advanced over a guidewire previously inserted into the patient's vasculature. Moreover, the disclosed delivery methods are not intended to be limited. Any prosthetic valve disclosed herein can be implanted using any of a variety of delivery procedures and delivery devices known in the art.

[0108] Sterilization

[0109] Any of the systems, devices, equipment, etc. herein can be sterilized (e.g., using heating / heat, pressure, steam, radiation, and / or chemicals, etc.) to ensure that they are safe for use by patients, and as a step in the steps of the method, any method in the method herein can include the sterilization of associated systems, devices, equipment, etc. The example of heating / thermal sterilization includes steam sterilization and autoclave. The example of radiation for sterilization includes, but is not limited to, gamma radiation, ultraviolet radiation, and electron beam. The example of chemicals for sterilization includes, but is not limited to, ethylene oxide, hydrogen peroxide, peracetic acid, formaldehyde, and glutaraldehyde. Sterilization with hydrogen peroxide can be accomplished using, for example, hydrogen peroxide plasma.

[0110] simulation

[0111] The therapeutic techniques, methods, steps, etc. described or suggested herein or in references incorporated herein may be performed on living animals or on non-living simulated objects, such as cadavers, cadaver hearts, anthropomorphic false targets, simulators (e.g., having simulated body parts, tissues, etc.), etc.

[0112] Additional Examples of Disclosure Techniques

[0113] Considering the above implementation of the disclosed subject matter, the present application discloses the additional examples listed below. It should be noted that one feature of a separate example or one or more features of the examples adopted in combination, and optionally combined with one or more features of one or more other examples, are other examples that also fall within the disclosure of the present application.

[0114] Example 1. A prosthetic heart valve comprising: a radially expandable frame comprising a plurality of interconnected struts; and a plurality of leaflets disposed within the frame and configured to regulate blood flow through the frame in one direction, wherein each leaflet is folded along an axially extending fold to form an inner layer and an outer layer, wherein the inner layer of each leaflet is configured to engage with the inner layers of other leaflets, and wherein the length of the inner layer in the circumferential direction gradually increases as the frame radially expands.

[0115] Example 2. A prosthetic heart valve as described in any example herein, in particular example 1, wherein the length of the outer layer in the circumferential direction gradually decreases when the frame expands radially.

[0116] Example 3. A prosthetic heart valve as described in any example herein, particularly example 1 or example 2, wherein the leaflet has a pointed edge portion connected to the frame with sutures.

[0117] Example 4. A prosthetic heart valve as described in any example herein, in particular Example 3, wherein the pointed edge portion is sewn to an inner skirt disposed between the leaflet and an inner surface of the frame.

[0118] Example 5. A prosthetic heart valve as described in any of the examples herein, in particular any of examples 1 to 4, wherein the pointed edge portion is generally v-shaped or u-shaped.

[0119] Example 6. A prosthetic heart valve as described in any example herein, in particular any one of Examples 1 to 5, wherein each leaflet is formed from a separate piece of material.

[0120] Example 7. A prosthetic heart valve as described in any example herein, in particular any one of Examples 1 to 5, wherein the plurality of leaflets are formed from a continuous sheet of material.

[0121] Example 8. A prosthetic heart valve as described in any of the examples herein, particularly any of Examples 1 to 7, wherein the plurality of leaflets are operable to regulate blood flow through the frame in one direction at each diameter within a working diameter range of the frame.

[0122] Example 9. A prosthetic heart valve as described in any example herein, in particular example 8, wherein each leaflet is deployed at a maximum working diameter within the working diameter range.

[0123] Example 10. A prosthetic heart valve comprising: a frame comprising a plurality of interconnected struts, wherein the frame can radially expand between at least a first diameter and a larger second diameter; and a plurality of leaflets disposed within the frame and configured to regulate blood flow through the frame in one direction when the frame radially expands to the first diameter and when the frame radially expands to the second diameter, wherein each leaflet is folded along a longitudinal fold to form an inner layer and an outer layer, wherein each longitudinal fold defines a pair of adjacent inner layer commissures for two adjacent leaflets, wherein the inner layer of each leaflet defines a joining edge, the joining edge being configured to move inward and outward in a radial direction relative to the outer layer at the commissure.

[0124] Example 11. A prosthetic heart valve as described in any of the examples herein, in particular Example 10, wherein the length of the inner layer of each leaflet in the circumferential direction increases when the frame radially expands from the first diameter to the second diameter.

[0125] Example 12. A prosthetic heart valve as described in any of the examples herein, particularly Example 10 or Example 11, wherein the length of the outer layer of each leaflet in the circumferential direction decreases when the frame radially expands from the first diameter to the second diameter.

[0126] Example 13. A prosthetic heart valve as described in any of the examples herein, in particular Example 12, wherein the inner layer of each leaflet tightens the material of the outer layer at the folded portion so that as the frame expands radially, the length of the inner layer increases and the length of the outer layer decreases.

[0127] Example 14. A prosthetic heart valve as described in any example herein, in particular any one of Examples 10 to 13, wherein the distance between adjacent folds in the circumferential direction increases as the frame expands radially.

[0128] Example 15. A prosthetic heart valve as described in any example herein, in particular any one of Examples 10 to 14, wherein the distance between adjacent commissures in the circumferential direction increases as the frame expands radially.

[0129] Example 16. A prosthetic heart valve as described in any of the examples herein, in particular any of Examples 10 to 15, wherein the fold of one leaflet of the plurality of leaflets is positioned radially inward of a portion of an adjacent leaflet.

[0130] Example 17. A prosthetic heart valve as described in any of the examples herein, in particular any of Examples 10 to 16, wherein the prosthetic heart valve includes the same number of leaflets when the frame radially expands to the first diameter and when the frame radially expands to the second diameter.

[0131] Example 18. A prosthetic heart valve as described in any of the examples herein, in particular any of Examples 10 to 17, wherein the frame can radially expand to a third diameter that is greater than the second diameter; and wherein the plurality of leaflets are configured to regulate the blood flow through the frame in one direction when the frame radially expands to the third diameter.

[0132] Example 19. A prosthetic heart valve as described in any example herein, in particular any one of Examples 10 to 18, wherein the plurality of leaflets are formed from a continuous sheet of material.

[0133] Example 20. A prosthetic heart valve comprising: a radially expandable frame comprising a plurality of interconnected struts; and a plurality of self-adjustable leaflets disposed within the frame, each leaflet comprising a longitudinal fold defining an outer layer and an inner layer, wherein the inner layer of a first leaflet comprises a non-engaged portion and a engaged portion, wherein the non-engaged portion of the first leaflet is disposed radially outside of the outer layer of a second leaflet, wherein each engaged portion is configured to move inward and outward in a radial direction relative to the outer layer at the longitudinal fold.

[0134] Example 21. A prosthetic heart valve as described in any of the examples herein, in particular Example 20, wherein the longitudinal fold of the first leaflet is aligned with the end of the joint portion of the second leaflet to define a commissure between the first leaflet and the second leaflet.

[0135] Example 22. A prosthetic heart valve as described in any example herein, in particular Example 21, wherein a distance between adjacent commissures in a circumferential direction increases as the frame radially expands.

[0136] Example 23. A prosthetic heart valve as described in any of the examples herein, in particular any of Examples 20 to 22, wherein the non-engaged portion of the first leaflet is connected to the outer layer of the second leaflet.

[0137] Example 24. A prosthetic heart valve as described in any of the examples herein, in particular any of Examples 20 to 23, wherein the length of the inner layer increases linearly as the frame expands radially, and the length of the outer layer decreases linearly as the frame expands radially.

[0138] Example 25. A prosthetic heart valve as described in any example herein, in particular any one of Examples 20 to 24, wherein the plurality of leaflets are formed from a continuous sheet of material.

[0139] Example 26. A prosthetic heart valve as described in any of the examples herein, in particular any of Examples 20 to 25, wherein the outer layer of the first leaflet is disposed radially outward of the inner layer of the first leaflet at the longitudinal fold.

[0140] Example 27. A prosthetic heart valve comprising: a frame comprising a plurality of leaflet attachment members; and a leaflet structure disposed within the frame and attached to the frame at the plurality of leaflet attachment members, the leaflet structure defining leaflets between each of the plurality of leaflet attachment members, wherein each leaflet comprises a longitudinal fold defining an inner layer and an outer layer, wherein each fold is circumferentially offset from the plurality of leaflet attachment members, wherein the inner layer of the leaflet is configured to move inward and outward in a radial direction relative to the frame to regulate blood flow through the frame.

[0141] Example 28. A prosthetic heart valve as described in any of the examples herein, in particular Example 27, wherein the leaflet structure is attached to the plurality of leaflet attachment members using sutures.

[0142] Example 29. A prosthetic heart valve as described in any of the Examples herein, in particular Example 27 or Example 28, wherein the frame can radially expand within a certain diameter range; and wherein when the frame radially expands from a first diameter within the diameter range to a second larger diameter within the diameter range, the circumferential length of the offset between the folded portion and the leaflet attachment member decreases.

[0143] Example 30. A prosthetic heart valve as described in any example herein, in particular Example 29, wherein the circumferential length of the inner layer increases as the frame radially expands from the first diameter to the second diameter.

[0144] Example 31. A prosthetic heart valve as described in any example herein, particularly Example 29 or Example 30, wherein the circumferential length of the outer layer decreases as the frame radially expands from the first diameter to the second diameter.

[0145] Example 32. A prosthetic heart valve as described in any of the examples herein, in particular any of Examples 27 to 31, wherein the leaflet construction comprises a single continuous sheet of material that defines all of the leaflets.

[0146] Example 33. A prosthetic heart valve as described in any of the examples herein, in particular any of Examples 27 to 31, wherein the leaflet structure includes separate pieces of material that each form one of the leaflets.

[0147] Example 34. A prosthetic heart valve, comprising: a radially expandable frame; and a leaflet structure, which is arranged within the frame and includes a plurality of leaflets, each leaflet including a longitudinal fold portion defining an inner layer and an outer layer, each inner layer having a non-bonded section and a bonded section, wherein a first outer layer is connected to a bonded section of the first inner layer and a non-bonded section of the second inner layer, wherein the first outer layer is arranged radially outside the bonded section of the first inner layer, wherein the first outer layer is arranged radially inside the non-bonded section of the second inner layer, wherein the length of the inner layer in the circumferential direction gradually increases when the leaflet assembly radially expands, and wherein the length of the outer layer in the circumferential direction gradually decreases when the leaflet assembly radially expands.

[0148] Example 35. A prosthetic heart valve as described in any of the examples herein, in particular Example 34, wherein the second outer layer is connected to a joined segment of the second inner layer and a non-joined segment of the third inner layer, wherein the second outer layer is disposed radially inward of the non-joined segment of the third inner layer.

[0149] Example 36. A prosthetic heart valve as described in any example herein, particularly example 34 or example 35, wherein the frame is expandable within a working diameter range.

[0150] Example 37. A prosthetic heart valve as described in any of the examples herein, in particular any of Examples 34 to 36, wherein the first inner layer tightens the material of the first outer layer at the folded portion so that as the frame expands radially, the length of the first inner layer increases and the length of the first outer layer decreases.

[0151] Example 38. A prosthetic heart valve as described in any of the examples herein, in particular any of Examples 34 to 37, further comprising sutures connecting the plurality of leaflets to the frame.

[0152] Example 39. A prosthetic heart valve as described in any of the examples herein, in particular any of Examples 34 to 38, wherein the plurality of leaflets are formed from a continuous sheet of material.

[0153] Example 40. A leaflet structure for a prosthetic heart valve, comprising: three inner layers, each inner layer having a non-bonded segment and a bonded segment; three outer layers connected to the three inner layers, wherein a first outer layer of the three outer layers is connected to a bonded segment of the first inner layer and a non-bonded segment of the second inner layer, wherein the first outer layer is disposed radially outside the bonded segment of the first inner layer, wherein a second outer layer of the three outer layers is connected to a bonded segment of the second inner layer and a non-bonded segment of the third inner layer, wherein the second outer layer is disposed radially inside the non-bonded segment of the third inner layer; at least one longitudinal fold positioned between each inner layer and the corresponding outer layer; wherein the length of the inner layer in the circumferential direction gradually increases when the leaflet structure radially expands; and wherein the length of the outer layer in the circumferential direction gradually decreases when the leaflet structure radially expands.

[0154] Example 41. A leaflet structure as described in any of the examples herein, in particular Example 40, wherein the engagement segment of the second inner layer is configured to move inwardly and outwardly in a radial direction relative to the second outer layer under the blood flow.

[0155] Example 42. A leaflet structure as described in any of the examples herein, in particular Example 40 or Example 41, wherein the second inner layer tightens the material of the second outer layer at the folded portion so that as the leaflet structure expands radially, the length of the second inner layer increases and the length of the second outer layer decreases.

[0156] Example 43. A delivery assembly comprising: a delivery device comprising an expansion mechanism; and a prosthetic heart valve connected to the delivery device, the prosthetic heart valve comprising: a radially expandable frame; and a plurality of leaflets disposed within the frame and configured to regulate blood flow through the frame in one direction, wherein each leaflet is folded along a longitudinal fold to form an inner layer and an outer layer, wherein the inner layer of each leaflet is configured to engage with the inner layers of other leaflets, and wherein the length of the inner layer in the circumferential direction gradually increases when the expansion mechanism radially expands the frame.

[0157] Example 44. A delivery assembly as described in any of the examples herein, in particular Example 43, wherein the expansion mechanism is one of: a balloon on which the prosthetic heart valve is mounted, a mechanical actuator that applies an expansion force to the prosthetic heart valve, and a sheath of the delivery device, the sheath deploying the prosthetic heart valve so that the prosthetic heart valve self-expands to the functional size of the prosthetic heart valve.

[0158] Example 45. A delivery assembly as described in any example herein, particularly example 43 or example 44, wherein the distance between adjacent folds in the circumferential direction increases as the frame expands radially.

[0159] Example 46. A delivery assembly as described in any of the examples herein, in particular any of Examples 43 to 45, wherein the frame can be radially expanded to each diameter within a certain diameter range; and wherein the plurality of leaflets are configured to regulate the blood flow through the frame when the frame is expanded to each diameter within the diameter range.

[0160] Example 47. A delivery assembly as described in any example herein, particularly Example 46, wherein the diameter range is 20 mm to 30 mm.

[0161] Example 48. A delivery assembly as described in any example herein, particularly Example 46, wherein the diameter range is 25 mm to 40 mm.

[0162] Example 49. A delivery assembly as described in any example herein, particularly Example 46, wherein the diameter range is 40 mm to 60 mm.

[0163] Example 50. An implantation method, comprising: inserting a delivery device into a patient's blood vessel, the delivery device comprising a radially expandable prosthetic heart valve; and expanding the prosthetic heart valve within or near a natural valve of the patient's heart to a first diameter within a diameter range of the prosthetic heart valve, the prosthetic heart valve comprising a leaflet having a folded portion, the folded portion defining a leaflet inner layer and a leaflet outer layer, the leaflet inner layer and the leaflet outer layer sliding relative to each other when the prosthetic heart valve expands.

[0164] Example 51. A method as described in any of the examples herein, in particular Example 50, wherein expanding the prosthetic heart valve to the first diameter includes increasing the length of the inner layer of the leaflet in the circumferential direction and decreasing the length of the outer layer of the leaflet in the circumferential direction.

[0165] Example 52. A method as described in any of the examples herein, particularly Example 50 or Example 51, further comprising expanding the prosthetic heart valve to a second diameter within the diameter range, wherein the second diameter is greater than the first diameter.

[0166] Example 53. A method as described in any of the examples herein, particularly Example 52, wherein expanding the prosthetic heart valve to the second diameter includes unfolding the folded portion of the leaflet.

[0167] Example 54. A method of delivering an implant within a patient's body, the implant comprising the prosthetic heart valve of any one of Examples 1 to 35, the method comprising: positioning the prosthetic heart valve at an implantation site within the patient's body; and expanding the prosthetic heart valve to a working diameter within a working diameter range of the prosthetic heart valve.

[0168] Example 55. A method as described in any of the examples herein, in particular Example 54, wherein expanding the prosthetic heart valve to the working diameter includes sliding an inner layer of the leaflet relative to an outer layer of the leaflet at a folded portion of the leaflet such that the length of the inner layer increases and the length of the outer layer decreases.

[0169] Example 56. A method as described in any example herein, particularly Example 54 or Example 55, further comprising expanding the prosthetic heart valve to a larger working diameter.

[0170] Example 57. A method as described in any example herein, in particular Example 56, further comprising expanding the leaflet.

[0171] Example 58. A prosthetic heart valve as described in any example herein, in particular any one of Examples 1 to 39, wherein the prosthetic heart valve is sterilized.

[0172] Example 59. A leaflet structure as described in any example herein, in particular any one of Examples 40 to 42, wherein the leaflet structure is sterilized.

[0173] Example 60. A delivery assembly as described in any example herein, particularly any one of Examples 43 to 49, wherein the delivery assembly is sterilized.

[0174] Unless otherwise stated, features described herein with respect to any example may be combined with other features described in any one or more of the other examples. For example, any one or more of the features of one prosthetic heart valve may be combined with any one or more of the features of another prosthetic heart valve.

[0175] In view of the many possible examples to which the principles of the disclosed technology can be applied, it should be recognized that the examples shown are merely preferred examples of the disclosed technology and should not be taken as limiting the scope of the claimed subject matter. Rather, the scope of the claimed subject matter is defined by the following claims and their equivalents.

Claims

1. A delivery device, characterized in that include: handle; a steerable outer shaft extending distally from the handle; an intermediate shaft extending proximally from the handle and distally from the handle; and an inner shaft extending coaxially distally from the handle through the intermediate shaft and the outer shaft and coaxially extending proximally from the handle through the intermediate shaft; Wherein the intermediate shaft includes a proximal end portion extending proximally from the proximal end of the handle to the adapter, and wherein the adapter includes a first port configured to receive a guidewire and a second port configured to receive a fluid from a fluid source. 2 . The delivery device of claim 1 , wherein a rotatable knob is mounted on the proximal end portion and is configured to rotate the intermediate shaft about a central longitudinal axis and relative to the outer shaft.

3. The delivery device of claim 1, wherein the second port is fluidly coupled to an inner lumen of the intermediate shaft.

4. The delivery device of claim 1, wherein the intermediate shaft further comprises a distal end portion that extends distally beyond the distal end of the outer shaft when the distal end of the outer shaft is positioned away from the inflatable balloon of the delivery device.

5. The delivery device of claim 4, wherein the distal portion of the inner shaft extends distally beyond the distal end portion of the intermediate shaft.

6. The delivery device of claim 4, wherein the inflatable balloon is coupled to the distal end portion of the intermediate shaft.

7. The delivery device of claim 4, wherein the distal end of the inflatable balloon is coupled to the distal end of the delivery device.

8. The delivery device of claim 4, wherein an annular space is defined between an outer surface of the inner shaft and an inner surface of the intermediate shaft and is configured to receive the fluid from the fluid source via the second port of the adapter.

9. The delivery device of claim 8, wherein the annular space is fluidly coupled to a fluid passage formed between an outer surface of a distal end portion of the inner shaft and an inner surface of the inflatable balloon.

10. The delivery device of claim 1, wherein the handle comprises a steering mechanism configured to adjust the curvature of a distal end portion of the delivery device, and wherein the handle further comprises an adjustment mechanism and an associated locking mechanism.

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